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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 June 1985 to 06 June 1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(three animals instead of six used)
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Deviations:
yes
Remarks:
(three animals instead of six used)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dichlobenil
EC Number:
214-787-5
EC Name:
Dichlobenil
Cas Number:
1194-65-6
Molecular formula:
C7H3Cl2N
IUPAC Name:
2,6-dichlorobenzonitrile
Test material form:
solid: particulate/powder
Details on test material:
- Physical state: solid
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.0-2.5 kg
- Housing: stainless steel wire cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18-20 °C
- Humidity: 685-85 %
- Air changes: 16 times per hour
- Photoperiod: 12 hours light/12 hours dark

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Remarks:
test material moistened with 1 % tragacanth suspension
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
Three
Details on study design:
TEST SITE
- Type of wrap if used: 6 cm^2 aluminium foil patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Erythema and eschar formation
No erythema - 0
Very slight erythema (barely perceptible) - 1
Well-defined erythema - 2
Moderate to severe erythema - 3
Severe erythema (beet redness); eschar formation (injuries in depth) - 4

Oedema formation
No oedema - 0
Very slight oedema (barely perceptible) - 1
Slight oedema (edges of area well-defined by definite raising) - 2
Moderate oedema (raised approximately 1 mm) - 3
Severe oedema (raised more than 1 mm, extending beyond the area of exposure) - 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No erythema or oedema was noted during the exposure or during the 72-hour observation period.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the test, the test material was determined to be non-irritating.
Executive summary:

In a GLP compliant skin irritation study conducted in line with standardised guidelines OECD 404 and EPA OPP 85-1, the skin irritation of the test material was determined.

Under the conditions of the test, the test material was determined to be non-irritating.